Relay Plus Thoracic Stent-Graft System

Basic Information

• Brand Name: Relay Plus Thoracic Stent-Graft System
• Primary DI: 00843576102415
• Version / Model: 28-M338250342590U
• Catalog Number: 28-M338250342590U
• Company Name: Bolton Medical Inc.
• Labeler DUNS: 847424462
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-02
• Public Version: 2
• Public Version Date: 2023-05-10
• Public Version Status: Update
• Public Device Record Key: 0b11e821-c8d0-477b-92d7-2dd972948b13

Device Description

Endovascular stent-graft system

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MIH	System, Endovascular Graft, Aortic Aneurysm Treatment	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
48060	Descending thoracic aorta endovascular stent-graft	A non-bioabsorbable tubular device intended to be implanted within the descending thoracic aorta to repair the vessel [includes repair of thoracic aortic aneurysm (TAA), traumatic transsections/dissections, fistulae, penetrating ulcers]. It is typically made of a metal alloy [e.g., nickel-titanium alloy (Nitinol)] that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft) and is typically designed as a single continuous tube which may be used in singular and/or modular configurations. It is intended for percutaneous introduction; disposable delivery device (e.g., balloon catheter) may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00843576102415	GS1

Premarket Submissions

Submission Number	Supplement Number
P110038	000
P110038	001
P110038	002
P110038	004
P110038	005
P110038	006
P110038	008
P110038	009
P110038	010
P110038	011
P110038	012
P110038	013
P110038	014
P110038	015
P110038	016
P110038	017
P110038	018
P110038	021
P110038	022
P110038	023
P110038	024
P110038	025
P110038	026

Device Sizes

Type	Value	Unit	Text
Outer Diameter	34	Millimeter
Length	250	Millimeter
Outer Diameter	38	Millimeter
Catheter Gauge	25	French

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius